新型冠状病毒抗体检测结果的标准化和平行比较

Normalization and parallel comparison of the detection results of antibodies against SARS-CoV-2

目的通过世界卫生组织(world health organization,WHO)新型冠状病毒(severe acute respiratory syndrome coronavirus 2,SARS-CoV-2)抗体国际标准品(international standard,IS)(G样本)、抗体参考盘(样本E、F、H、I、J)的应用降低SARS-CoV-2抗体检测结果差异、提高检测结果一致性。方法利用基于SARS-CoV-2活病毒的微量中和试验、假病毒中和试验以及商品化的ELISA试剂盒对WHO的SARS-CoV-2抗体IS和参考盘等共10个样本(A~J)分别进行检测,对检测结果进行分析比较。结果以IS为参考品确定其他样本的相对浓度,降低了检测结果之间的差异。假病毒中和试验、ELISA检测血清抗体参考盘结果与基于SARS-CoV-2 HB02株的中和试验基本一致,个别试剂可检测弱阳性样本。结论SARS-CoV-2抗体IS的使用促进了血清学检测方法的标准化,抗体参考盘适用于基于SARS-CoV-2原型株的所有检测方法,假病毒中和试验、ELISA等在一定程度上可作为活病毒中和试验的替代方法。

Objective To improve the consistency of test results through reducing inter-laboratory variation in SARS-CoV-2 antibody detection with WHO SARS-CoV-2 antibody candidate international standard(IS,sample G)and antibody reference panel(samples E,F,H,I,J).Methods Ten WHO samples(A-J)including the candidate IS and reference panel were evaluated using different methods,such as microneutralization tests based on live SARS-CoV-2,pseudovirus neutralization assay and commercial ELISA kits.The test results were compared using statistical analysis.Results Using IS(sample G)as a reference,the relative concentrations of other samples could be determined with less variation.ELISA and pseudovirus neutralization assay had consistent results with those obtained with the microneutralization test based on SARS-COV-2 strain HB02.Weakly positive samples could be detected only by a certain kit.Conclusions The availability of an IS for antibodies would facilitate the standardization of SARS-CoV-2 antibody detection methods.The reference panel fitted all the assays based on the SARS-CoV-2 prototype Wuhan strain.Pseudovirus neutralization assay and ELISA could be used as alternatives to live SARS-CoV-2-based neutralization test to some extent.